Reg, Med Affairs & Market Access Assoc
Careerwise Recruitment
Leinster, Dublin
A Regulatory, Medical Affairs and Market Access Associate is required by CareerWise Recruitment for our West Dublin based multinational pharmaceutical client. The position offers significant future development opportunity (medical affairs and business) for the right candidate as this client continues to expand. This is a 12-month contract with potential for permanency. Candidates from regulated environments such as the biopharmaceutical, pharmaceutical or medical devices industry will be considered. THE ROLE: * Ensure regulatory & medical compliance within the marketing company. * Full compliance to GXP requirements as per local QMS, SOP's and standards. * Prepare local regulatory & medical SOP's. * Ensure market access dossiers are compliant with internal and external standards and requirements. * Ensure EAP administration compliance to internal and external standards and requirements. * Provision of support to Medical and Market Access leads as driven by business priorities. * Nominated Signatory responsible for the review and approval of meetings, sponsorships and promotional/non-promotional materials in assigned Therapy Areas as required. * Update to local Medical and regulatory SOPs ensuring alignment with and compliance to global SOP/policies and external regulations. * Liaison with Marketing Company to communicate product changes (e.g. updates to the Summary of product characteristics) ensuring appropriate action is taken with respect to recall of materials and communication to external market where needed. * Management of Product Discontinuation notifications to internal and external stakeholders, carried out in line with local SOP. * GXP Responsibilities: Acting as the local Good Pharmacovigilance (GVP) Lead ensuring PV responsibilities for Ireland are met. * Acting as the Local Deputy Recall Administrator and provision of support to manage product quality issues and stock shortages in Ireland. * Contribute to the preparation of HTA dossiers and other reimbursement documents to be submitted to payers. * Support the preparation of presentations for internal and external use. * Prepare documentation for local compliance approval, e.g. Market Access materials for external use, congress attendance. * Provide other ad hoc Market Access support as determined by the needs of the business. REQUIREMENTS: * 2 years' experience in a regulatory/medical environment in pharma or a CRO. * University Degree in life sciences or related disciplines. * Excellent working knowledge of the Irish Regulatory requirements, IPHA industry code and Irish regulatory and compliance frameworks. * Good knowledge of Irish pharmaceutical legislation. * Excellent written & verbal communication skills plus attention to detail. * Performance driven and customer focussed. * IT Literacy (MS Word, Excel, PowerPoint, Sales Logix, Atlas, Veeva, EndNote. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.
2030 days ago